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临床试验/NCT02686580
NCT02686580终止3 期

Feasibility Study to Assess the Early Use of Porcine Cross-linked Collagen Paste in Cryptoglandular Anorectal Fistulas

Royal Devon and Exeter NHS Foundation Trust0 个研究点目标入组 2 人开始时间: 2016年2月1日最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
终止
发起方
入组人数
2
主要终点
Fistula Healing rate at 3 months

研究概览

简要总结

This study is designed to assess the effectiveness of porcine cross-linked collagen paste for the treatment of patients with ano-rectal abscess with underlying cryptoglandular fistula in ano.

详细描述

Most anal fistulae are thought to arise as a result of the infection of anal glands. This infection frequently presents as an anorectal abscess which requires drainage of the abscess under a general anaesthetic. Abscess and fistula should be considered as the acute and chronic phase of the same anorectal infection.The abscess represents the acute inflammatory event, whereas the fistula is representative of the chronic process. At the time of drainage of the anorectal abscess, the underlying fistulas frequently go undetected. As a result, patients present with a fistula in ano several months later.

In this study, the investigators aim to identify the underlying fistula in patients with a perianal abscess with the help of an MRI Scan done in the acute setting. Participants with a confirmed fistula on the MRI scan have their abscess treated as per convention. However, a repeat examination under anaesthetic is performed 7-'10 days later when the fistula tract is identified and treated with injection of the porcine collagen paste into the fistula tract. Participants are followed up clinically and radiologically to assess the effectiveness of the intervention.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Inclusion Criteria:
  • o Clinical diagnosis of Cryptoglandular fistula in ano.

排除标准

  • Insulin dependent diabetes
  • Thyroid disease
  • Fistula secondary to Crohn's disease/Ulcerative Colitis
  • Clinical or radiological evidence of secondary tracts.
  • Complex fistula tracts on MRI scan such as Horseshoe fistula, anorectal-vaginal fistula
  • Patients refusing informed consent for admission to the study.
  • Previous fistulotomy/fistulectomy
  • Pregnancy
  • Patients unable to consent
  • Patients not suitable for MRI scan those with- Cochlear implant, Permanent pacemaker, Implanted metal work, Aneurysm clips, Claustrophobia, Metallic foreign body

研究组 & 干预措施

Collagen paste

Experimental

Injection of Permacol Collagen paste into the fistula tract.

干预措施: Collagen paste (Biological)

结局指标

主要结局

Fistula Healing rate at 3 months

时间窗: 3 months

Healing of fistula as evidenced by MRI of the ano-rectum.

Fistula Healing Rate at 12 months

时间窗: 12 months

This will be assessed by a telephonic questionnaire at 12 months following intervention

次要结局

  • Faecal Incontinence questionnaire (Wexner)(At recruitment, 7-10 days, 6 weeks and 6 months)
  • Faecal Incontinence quality of life questionnaire (FIQL)(At recruitment, 7-10 days, 6 weeks and 6 months)
  • Complication rate(12 months)
  • Pain Score(At recruitment, 7-10 days, 6 weeks and 6 months)

研究者

发起方
Royal Devon and Exeter NHS Foundation Trust
申办方类型
Other
责任方
Sponsor

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